Cleared Traditional

K943662 - LAPARASCOPE (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943662 · Pollux Endoscopy, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
301d
Days
Class 2
Risk

K943662 is an FDA 510(k) clearance for the LAPARASCOPE. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Pollux Endoscopy, Inc. (Sunrise, US). The FDA issued a Cleared decision on May 25, 1995 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pollux Endoscopy, Inc. devices

Submission Details

510(k) Number K943662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1994
Decision Date May 25, 1995
Days to Decision 301 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 160d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HET Laparoscope, Gynecologic (and Accessories)

All 337
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K943662.
SIRIUS Endoscope System (PR-SI-1230)
K250939 · Precision Robotics (Hong Kong) Limited · Aug 2025
i-Cut
K243821 · A.M.I. Agency For Medical Innovations GmbH · Apr 2025
SIRIUS Endoscope System
K221642 · Precision Robotics (Hong Kong) Limited · Dec 2022
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
K201832 · Olympus Medical Systems Corp. · Sep 2021